Digesan

Digesan may be available in the countries listed below.

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Bromopride

Bromopride is reported as an ingredient of Digesan in the following countries:

• Brazil

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Pantagon may be available in the countries listed below.

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Pantoprazole

Pantoprazole is reported as an ingredient of Pantagon in the following countries:

• India

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Natrilix SR

Natrilix SR may be available in the countries listed below.

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Indapamide

Indapamide is reported as an ingredient of Natrilix SR in the following countries:

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Indapamide hemihydrate (a derivative of Indapamide) is reported as an ingredient of Natrilix SR in the following countries:

• Vietnam

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Nisopred

Nisopred may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

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Chlorphenamine

Chlorphenamine maleate (a derivative of Chlorphenamine) is reported as an ingredient of Nisopred in the following countries:

• France

Prednisolone

Prednisolone is reported as an ingredient of Nisopred in the following countries:

• France

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Nitrendipina

Nitrendipina may be available in the countries listed below.

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Nitrendipine

Nitrendipina (DCIT) is also known as Nitrendipine (Rec.INN)

International Drug Name Search

Glossary

DCIT	Denominazione Comune Italiana
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

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Niglinar

Niglinar may be available in the countries listed below.

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Nitroglycerin

Nitroglycerin is reported as an ingredient of Niglinar in the following countries:

• Argentina


• Peru

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Testoviron-Depot Paranova

Testoviron-Depot Paranova may be available in the countries listed below.

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Testosterone

Testosterone mixt. of esters (a derivative of Testosterone) is reported as an ingredient of Testoviron-Depot Paranova in the following countries:

• Denmark

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Parafil

Parafil may be available in the countries listed below.

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Paracetamol

Paracetamol is reported as an ingredient of Parafil in the following countries:

• Ethiopia

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Fenticonazole Nitrate

Fenticonazole Nitrate may be available in the countries listed below.

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Fenticonazole

Fenticonazole Nitrate (BANM, USAN) is also known as Fenticonazole (Rec.INN)

International Drug Name Search

Glossary

BANM	British Approved Name (Modified)
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

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Butler Fluodent Foam N

Butler Fluodent Foam N may be available in the countries listed below.

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Sodium Fluoride

Sodium Fluoride is reported as an ingredient of Butler Fluodent Foam N in the following countries:

• Japan

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Fenitoina Genfarma

Fenitoina Genfarma may be available in the countries listed below.

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Phenytoin

Phenytoin sodium salt (a derivative of Phenytoin) is reported as an ingredient of Fenitoina Genfarma in the following countries:

• Spain

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Glimepirid BMM Pharma

Glimepirid BMM Pharma may be available in the countries listed below.

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Glimepiride

Glimepiride is reported as an ingredient of Glimepirid BMM Pharma in the following countries:

• Sweden

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Lidocaina Cloridrato Biologici

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Lidocaine

Lidocaine hydrochloride (a derivative of Lidocaine) is reported as an ingredient of Lidocaina Cloridrato Biologici in the following countries:

• Italy

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Diviplus

Diviplus may be available in the countries listed below.

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Estradiol

Estradiol 17ß-valerate (a derivative of Estradiol) is reported as an ingredient of Diviplus in the following countries:

• Belgium

Medroxyprogesterone

Medroxyprogesterone 17α-acetate (a derivative of Medroxyprogesterone) is reported as an ingredient of Diviplus in the following countries:

• Belgium

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Narcozep

Narcozep may be available in the countries listed below.

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Flunitrazepam

Flunitrazepam is reported as an ingredient of Narcozep in the following countries:

• France

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Tiemonio ioduro

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Tiemonium Iodide

Tiemonio ioduro (DCIT) is also known as Tiemonium Iodide (Rec.INN)

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Glossary

DCIT	Denominazione Comune Italiana
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

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Minims Gentamycine

Minims Gentamycine may be available in the countries listed below.

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Gentamicin

Gentamicin is reported as an ingredient of Minims Gentamycine in the following countries:

• Netherlands

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Soluderme

Soluderme may be available in the countries listed below.

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Betamethasone

Betamethasone 17α,21-dipropionate (a derivative of Betamethasone) is reported as an ingredient of Soluderme in the following countries:

• Portugal

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Strinacin

Strinacin may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

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Sulfadiazine

Sulfadiazine is reported as an ingredient of Strinacin in the following countries:

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Trimethoprim

Trimethoprim is reported as an ingredient of Strinacin in the following countries:

• United Kingdom

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Amlodipine Mylan

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Amlodipine

Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of Amlodipine Mylan in the following countries:

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Ascorgem

Ascorgem may be available in the countries listed below.

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Ascorbic Acid

Ascorbic Acid is reported as an ingredient of Ascorgem in the following countries:

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Denosumab

Class: Bone Resorption Inhibitors
Chemical Name: Anti-(human osteoclast differentiation factor) (human monoclonal AMG162 heavy chain), disulfide with human monoclonal AMG162 light chain immunoglobulin G2 dimer.
Molecular Formula: C₆₄₀₄H₉₉₁₂N₁₇₂₄O₂₀₀₄S₅₀
CAS Number: 615258-40-7
Brands: Prolia

REMS:

FDA approved a REMS for denosumab to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of denosumab and consists of the following: medication guide and communication plan. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Bone resorption inhibitor; fully human monoclonal antibody specific for nuclear factor kappa-B ligand (RANKL); RANKL inhibitor.^{1 10}

Uses for Denosumab

Osteoporosis (Prolia)

Treatment of osteoporosis in postmenopausal women at high risk of fracture, defined as history of osteoporotic fracture or multiple risk factors for fracture.¹

Treatment of osteoporosis in postmenopausal women who have failed or are intolerant of other available osteoporosis therapies.¹

Denosumab Dosage and Administration

General

• 
  

  Correct preexisting hypocalcemia prior to initiating denosumab.¹

  
  


• 
  

  All postmenopausal women receiving denosumab (Prolia) for treatment of osteoporosis should receive 1 g of calcium and at least 400 units of vitamin D daily.¹

  
  

Administration

Sub-Q Administration

Administer by sub-Q injection into upper arm, upper thigh, or abdomen.¹ Should be administered by a health-care professional.¹

May warm to room temperature by allowing drug to stand in original packaging at room temperature (≤25°C) for approximately 15–30 minutes.¹ Do not use any other method to warm the drug.¹

Solution should appear clear, colorless to pale yellow; may contain trace amounts of translucent to white proteinaceous particles.¹ Do not use if solution is discolored, cloudy, or contains many particles or foreign matter.¹

Single-use prefilled syringe (Prolia): Remove gray needle cap and inject entire solution.¹ After injection is complete, activate needle guard by pointing needle away from body and gently sliding green safety guard toward needle until locked securely in place.¹ The needle cap contains dry natural rubber (latex) and should not be handled by individuals sensitive to latex.¹ (See Latex Sensitivity under Cautions.)

Single-use vial (Prolia): Use a 27-gauge needle to withdraw and inject the dose.¹ Do not re-enter vial; discard any remaining solution along with the vial.¹

Dosage

Adults

Osteoporosis (Prolia)

Treatment in Postmenopausal Women

Sub-Q

60 mg once every 6 months.¹

Administer a missed dose as soon as patient is available; give subsequent doses every 6 months from date of last dose.¹

Special Populations

Hepatic Impairment

Pharmacokinetics not evaluated in patients with hepatic impairment.¹

Renal Impairment

Dosage adjustment of Prolia not necessary in patients with renal impairment.¹ However, those with severe renal impairment (Cl_cr <30 mL/minute) or receiving dialysis are at greater risk of developing hypocalcemia.¹ (See Hypocalcemia and Mineral Metabolism under Cautions.)

Cautions for Denosumab

Contraindications

• 
  

  Hypocalcemia; preexisting hypocalcemia must be corrected prior to initiating denosumab treatment.¹

  
  

Warnings/Precautions

Risk Evaluation and Mitigation Strategy (REMS) for Prolia

FDA required and approved a REMS for Prolia: goals are to inform health-care providers and patients about the serious risks associated with use of denosumab, including serious infections, adverse dermatologic reactions, and suppression of bone turnover.⁸

The REMS requires that a medication guide be provided to the patient with each denosumab (Prolia) dose, outlines a communication plan requiring initial and continuing communications to certain targeted groups of prescribers, and requires that the manufacturer periodically submit REMS assessments to FDA.⁸

Prescribers are encouraged to register with the Prolia Postmarketing Active Safety Surveillance Program, a voluntary program designed to collect information on adverse events of interest.^{1 13} Available at or 800-772-6436.^{1 13}

Hypocalcemia and Mineral Metabolism

Decreased serum calcium concentrations can occur; denosumab may exacerbate preexisting hypocalcemia.¹

Preexisting hypocalcemia must be corrected prior to initiating denosumab treatment.¹

All patients should receive adequate calcium and vitamin D supplementation.¹ (See General under Dosage and Administration.)

Risk of hypocalcemia is greater in patients with severe renal impairment (Cl_cr <30 mL/minute) or receiving dialysis.¹ Monitor such patients for symptoms of hypocalcemia and, like all patients, ensure adequate calcium and vitamin D supplementation.¹ (See Renal Impairment under Cautions.)

Clinical monitoring of calcium, phosphorus, and magnesium highly recommended in patients predisposed to hypocalcemia and disturbances of mineral metabolism (e.g., history of hypocalcemia, thyroid surgery, parathyroid surgery, malabsorption syndromes, excision of small intestine, severe renal impairment, receiving dialysis).¹

Serious Infections

Denosumab may increase risk of infection.¹

Serious skin infections (e.g., cellulitis, erysipelas), endocarditis, and infections of the abdomen, urinary tract, and ear reported in a clinical trial evaluating denosumab in postmenopausal women with osteoporosis;¹ some infections required hospitalization.¹

Patients receiving concomitant immunosuppressive agents or with impaired immune systems may be at greater risk of serious infections.¹ Assess need for continued denosumab (Prolia) treatment in patients who develop serious infections.¹

Dermatologic Reactions

Adverse epidermal and dermal events (e.g., dermatitis, eczema, rash) were reported in a clinical trial evaluating denosumab in postmenopausal women with osteoporosis; most reactions were not specific to the injection site.¹

If severe dermatologic symptoms develop, consider discontinuing denosumab (Prolia).¹

Osteonecrosis of the Jaw (ONJ)

ONJ has been reported in patients receiving denosumab.¹ ONJ generally is associated with tooth extraction and/or local infection with delayed healing, but may occur spontaneously.¹

Risk factors for ONJ include invasive dental procedures (e.g., tooth extraction, dental implants, oral surgery), diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids), poor oral hygiene, and comorbidities (e.g., preexisting dental disease, anemia, coagulopathy, infection, ill-fitting dentures).¹

Perform routine oral examination prior to initiating denosumab.¹ Consider referring patients with risk factors for ONJ for dental examination and preventive dentistry prior to initiating denosumab.¹

If invasive dental procedures are required, clinical judgment of the prescriber and/or oral surgeon and assessment of risks and benefits should guide the management plan.¹

If ONJ develops or is suspected, refer patient to dentist or oral surgeon.¹ Extensive dental surgery to treat ONJ may exacerbate the condition.¹ Consider discontinuing denosumab (Prolia) based on patient-specific risk-benefit assessment.¹

Suppression of Bone Turnover

Significant suppression of bone remodeling was observed in clinical trials of denosumab (Prolia) in postmenopausal women with osteoporosis.^{1 4}

Denosumab treatment results in reduction in biochemical bone turnover markers⁴ and bone formation rates (as shown by tetracycline labeling).¹

Long-term effects of the degree of bone remodeling suppression seen with denosumab are unknown.¹ Because these effects may contribute to adverse outcomes, such as ONJ, atypical fractures, and delayed fracture healing, monitor patients for such events.¹

Immunogenicity and Antibody Formation

Denosumab-binding antibodies (preexisting, transient, and developing antibodies) reported rarely in postmenopausal women with osteoporosis receiving denosumab for up to 5 years.¹ Denosumab-neutralizing antibodies not reported to date, and antibody formation does not appear to affect denosumab pharmacokinetics, toxicity, or efficacy.¹

Sensitivity Reactions

Latex Sensitivity

Prolia: Some packaging components (i.e., needle cap) of prefilled syringes contain natural latex proteins in the form of dry natural rubber (latex),¹ and should not be handled by individuals sensitive to latex.^{1 5 6 7}

Some individuals may be hypersensitive to natural latex proteins;^{5 6 7} rarely, hypersensitivity reactions to natural latex proteins have been fatal.^{6 7}

Specific Populations

Pregnancy

Category C.¹

Prolia: Indicated only in postmenopausal women.¹

Women who become pregnant during denosumab treatment are encouraged to enroll in the manufacturer's Pregnancy Surveillance Program at 800-772-6436.¹

Lactation

Not known whether denosumab is distributed into milk.¹ Discontinue nursing or drug.¹

Pediatric Use

Safety and efficacy not established.¹

Denosumab potentially may impair bone growth in children with open growth plates and may inhibit eruption of dentition.¹

Geriatric Use

No overall differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.¹

Hepatic Impairment

No pharmacokinetic studies performed in patients with hepatic impairment.¹

Renal Impairment

Pharmacokinetics not affected by renal impairment;¹ dosage adjustment not necessary.¹

Patients with severe renal impairment (Cl_cr <30 mL/minute) or receiving dialysis are at greater risk of hypocalcemia.¹ Consider risks and benefits of denosumab (Prolia) in such patients.¹ (See Hypocalcemia and Mineral Metabolism under Cautions.)

Common Adverse Effects

Prolia: Back pain,¹ extremity pain,¹ musculoskeletal pain,¹ hypercholesterolemia,¹ cystitis.¹

Interactions for Denosumab

No formal drug interaction studies to date.¹

Immunosuppressive Agents

Concomitant use with immunosuppressive agents may increase the risk of serious infections.¹ Assess risks and benefits to guide use of denosumab in patients receiving immunosuppressive agents.¹ (See Serious Infections under Cautions.)

Denosumab Pharmacokinetics

Absorption

Bioavailability

Approximately 61% following sub-Q administration.¹¹

Prolonged absorption phase;¹² maximum serum concentrations are attained approximately 10 days after a 60-mg sub-Q dose.¹

Characterization of other monoclonal antibodies indicates that absorption is probably mediated by the lymphatic system.^{3 14}

Onset

Studies in postmenopausal women with osteoporosis indicate reduction in bone resorption biomarkers observed within 3 days after a 60-mg dose; maximal reductions observed by 1 month.¹

Duration

Studies in postmenopausal women with osteoporosis indicate effect on bone resorption markers partially attenuated at the end of each 6-month dosing interval.¹ Bone mineral density and levels of bone resorption markers return to baseline within 12 months after discontinuing denosumab.¹

Distribution

Extent

Not known whether denosumab is distributed into milk.¹¹

Elimination

Elimination Route

Clearance may occur via the reticuloendothelial system; renal excretion is not expected.^{3 14}

Half-life

Approximately 25 days.¹

Special Populations

Pharmacokinetics not evaluated in patients with hepatic impairment;¹ pharmacokinetics not affected by renal impairment.¹

Stability

Storage

Parenteral

Injection for Sub-Q Use

2–8ºC; do not freeze.¹ Protect from direct light and heat.¹

Use within 14 days after removal from refrigerator.¹ Do not expose to temperatures >25ºC.¹

Do not shake vigorously.¹

Actions

• 
  

  Denosumab, a fully human monoclonal IgG₂ antibody, is a bone resorption inhibitor.^{1 10}

  
  


• 
  

  Denosumab is specific for and binds to nuclear factor kappa-B ligand (RANKL), and acts as a RANKL inhibitor preventing interaction with its receptor (RANK).^{1 10} The interaction between RANK and RANKL is integral to the normal bone resorption process.¹⁰ As a result, denosumab inhibits osteoclast formation, function, and survival and, ultimately, bone resorption.^{1 10}

  
  


• 
  

  In postmenopausal women with osteoporosis, denosumab increases bone mineral density (BMD) and reduces the incidence of vertebral, nonvertebral, and hip fractures.^{1 4}

  
  


• 
  

  The effects of denosumab are considered reversible since bone turnover markers and BMD return to baseline within 12 months after the drug is discontinued.^{1 10 12}

  
  

Advice to Patients

• 
  

  Denosumab (Prolia) medication guide must be provided to the patient each time the drug is administered; importance of reading the medication guide prior to initiating therapy and prior to each subsequent dose.^{1 2 8}

  
  


• 
  

  Importance of receiving adequate calcium and vitamin D supplementation during denosumab therapy, and importance of seeking medical attention if signs or symptoms of hypocalcemia develop (e.g., spasms, twitches, muscle cramps, numbness or tingling in fingers, toes, or near mouth).^{1 2}

  
  


• 
  

  Advise patients to seek prompt medical attention if they develop signs or symptoms of infection, including cellulitis (e.g., fever, chills, severe abdominal pain, frequent or urgent need to urinate or burning feeling when urinating, skin that is red, swollen, hot, or tender to touch).^{1 2}

  
  


• 
  

  Advise patients to seek prompt medical attention if they develop signs or symptoms of dermatologic reactions (e.g., redness, itching, rash, dry skin, blisters that ooze or crust, peeling skin).^{1 2}

  
  


• 
  

  Importance of maintaining good oral hygiene during denosumab treatment; importance of informing dentist about denosumab treatment prior to dental procedures.¹ Advise patients to inform clinician or dentist if persistent pain and/or slow healing of mouth or jaw occurs after dental surgery.¹

  
  


• 
  

  Importance of informing clinician about latex allergy.¹ (See Latex Sensitivity under Cautions.)

  
  


• 
  

  Inform postmenopausal women receiving denosumab (Prolia) for the treatment of osteoporosis that if a dose is missed, the dose should be given as soon as convenient and subsequent dose should be scheduled for 6 months from date of last dose.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹ Prolia is indicated only in postmenopausal women.¹ (See Pregnancy under Cautions.)

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Denosumab

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for subcutaneous use	60 mg/mL	Prolia	Amgen

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Xgeva 120MG/1.7ML Solution (AMGEN): 2/$1,900.01 or 5/$5,499.85

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Amgen. Prolia (denosumab) injection prescribing information. Thousand Oaks, CA. 2010 Jun.

2. Amgen. Prolia (denosumab) injection medication guide. Thousand Oaks, CA. 2010 Jun.

3. Lewiecki EM. Denosumab--an emerging treatment for postmenopausal osteoporosis. Expert Opin Biol Ther. 2010; 10:467-76. [PubMed 20095877]

4. Cummings SR, San Martin J, McClung MR et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009; 361:756-65. [PubMed 19671655]

5. Food and Drug Administration. Amended economic impact analysis of final rule requiring use of labeling on natural rubber containing devices. 21 CFR Part 801. Final rule. (Docket No. 96N-0119) Fed Regist. 1998; 63:50660-704.

6. Food and Drug Administration. Latex-containing devices; user labeling. 21 CFR Part 801. Proposed rule. (Docket No. 96N-0119) Fed Regist. 1996; 61:32617-21.

7. Food and Drug Administration. Natural rubber-containing medical devices; user labeling. 21 CFR Part 801. Final rule. (Docket No. 96N-0119) Fed Regist. 1997; 62:51021-30.

8. Prolia™ (densoumab) injection risk evaluation and mitigation stratetgy (REMS). From FDA website. Accessed Nov 12, 2010.

10. Romas E. Clinical applications of RANK-ligand inhibition. Intern Med J. 2009; 39:110-6. [PubMed 19356186]

11. Rodriquez, RD, Sutjandra L, Peterson MC, et al. Population pharmacokinetic meta-analysis of denosumab in healthy and cancer subjects and postmenopausal women with osteopenia or osteoporosis. The AAPS Journal.2009;11(S1).

12. Bekker PJ, Holloway DL, Rasmussen AS et al. A single-dose placebo-controlled study of AMG 162, a fully human monoclonal antibody to RANKL, in postmenopausal women. J Bone Miner Res. 2004; 19:1059-66. [PubMed 15176987]

13. Amgen. Prolia Postmarketing Active Safety Surveillance Program. Available at . Accessed August 26, 2010.

14. Lobo ED, Hansen RJ, Balthasar JP. Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci. 2004; 93:2645-68. [PubMed 15389672]

15. Food and Drug Administration Center for Drug Evaluation and Research. Summary review (application number 125320). From FDA website.

More Denosumab resources

• Denosumab Side Effects (in more detail)
• Denosumab Use in Pregnancy & Breastfeeding
• Denosumab Drug Interactions
• Denosumab Support Group
• 0 Reviews for Denosumab - Add your own review/rating

• Denosumab Professional Patient Advice (Wolters Kluwer)


• Denosumab MedFacts Consumer Leaflet (Wolters Kluwer)


• denosumab Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information


• Prolia Consumer Overview


• Prolia Prescribing Information (FDA)


• Xgeva Prescribing Information (FDA)


• Xgeva MedFacts Consumer Leaflet (Wolters Kluwer)


• Xgeva Consumer Overview

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In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Neo-Kanapront

Kanamycin

Kanamycin sulfate (a derivative of Kanamycin) is reported as an ingredient of Neo-Kanapront in the following countries:

• Italy

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Aknichthol N

Aknichthol N may be available in the countries listed below.

Ingredient matches for Aknichthol N

Ichthammol

Ichthammol sodium salt, decolorized (a derivative of Ichthammol) is reported as an ingredient of Aknichthol N in the following countries:

• Switzerland

Salicylic Acid

Salicylic Acid is reported as an ingredient of Aknichthol N in the following countries:

• Switzerland

International Drug Name Search

Adiro

Adiro may be available in the countries listed below.

Ingredient matches for Adiro

Aspirin

Acetylsalicylic Acid is reported as an ingredient of Adiro in the following countries:

• Spain

International Drug Name Search

Simlo

Simlo may be available in the countries listed below.

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Simvastatin

Simvastatin is reported as an ingredient of Simlo in the following countries:

• Mexico


• Russian Federation


• Vietnam

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Nitastin

Nitastin may be available in the countries listed below.

Ingredient matches for Nitastin

Simvastatin

Simvastatin is reported as an ingredient of Nitastin in the following countries:

• Greece

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Glucotrol XL

In the US, Glucotrol XL (glipizide systemic) is a member of the drug class sulfonylureas and is used to treat Diabetes, Type 2.

US matches:

• Glucotrol XL Extended-Release Tablets


• Glucotrol XL

Ingredient matches for Glucotrol XL

Glipizide

Glipizide is reported as an ingredient of Glucotrol XL in the following countries:

• Lithuania

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Sedesterol

Sedesterol may be available in the countries listed below.

Ingredient matches for Sedesterol

Dexamethasone

Dexamethasone phosphate (a derivative of Dexamethasone) is reported as an ingredient of Sedesterol in the following countries:

• Argentina

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Rabavert

Generic Name: rabies vaccine (Intramuscular route)

RAY-beez VAX-een

Commonly used brand name(s)

In the U.S.

• Imovax Rabies


• Rabavert

Available Dosage Forms:

• Injectable


• Powder for Solution


• Powder for Suspension

Therapeutic Class: Vaccine

Uses For Rabavert

Rabies vaccine is an active immunizing agent used to prevent infection caused by the rabies virus. The vaccine works by causing your body to produce its own protection (antibodies) against the rabies virus.

Rabies vaccine is used in two ways. Rabies vaccine is given to persons who have been exposed (e.g., by a bite, scratch, or lick) to an animal that is known, or thought, to have rabies. This is called post-exposure prophylaxis. Rabies vaccine may also be given ahead of time to persons who have a high risk of getting infected with rabies virus. These persons include veterinarians, animal handlers, or travelers who will spend more than 1 month in countries having a high rate of rabies infection, and persons who live, work, or take vacations in wild areas of the country where they are likely to come into contact with wild animals. This is called pre-exposure prophylaxis.

Rabies infection is a serious, and often fatal, infection. In the U.S., rabies in wild animals, especially raccoons, skunks, and bats, accounts for most cases of rabies passed on to humans, pets, and other domestic animals. In Canada, the animals most often infected with rabies are foxes, skunks, bats, dogs, and cats. Horses, swine, and cattle also have been known to become infected with rabies. In much of the rest of the world, including Latin America, Africa, and Asia, dogs account for most cases of rabies passed on to humans.

If you are being (or will be) treated for a possible rabies infection while traveling outside of the U.S. or Canada, contact your doctor as soon as you return to the U.S. or Canada, since it may be necessary for you to have additional treatment.

This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.

Before Using Rabavert

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This vaccine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many vaccines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of rabies vaccine in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Chloroquine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Illness, severe, with fever—The symptoms of the condition may be confused with the possible side effects of the vaccine.

• Immune deficiency condition, or family history of—May decrease the useful effects of the vaccine.

Proper Use of rabies vaccine

This section provides information on the proper use of a number of products that contain rabies vaccine. It may not be specific to Rabavert. Please read with care.

You will receive this vaccine while you are in a hospital or clinic. A nurse or other trained health professional will give you this vaccine. The vaccine is injected into the upper arm muscle (deltoid). Very young or small children may have the vaccine injected into the upper leg (thigh) muscle.

In order for the rabies vaccine to work properly, it is very important that you do not miss any doses. Keep your appointments with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  • For post-exposure prophylaxis if you have never received rabies vaccine before:
    
    • Adults and children—One dose on the first day after rabies exposure (day 0), then one dose three, seven, and fourteen days later for a total of four doses. On the first day, you will also receive an injection of the rabies immune globulin.
    
    
    • Adults and children with an immune system problem will need five doses of the vaccine. The last dose is given twenty-eight days after the first dose.
    
    
  
  
  • For post-exposure prophylaxis if you have received rabies vaccine before:
    
    • Adults and children—One dose on the first day, then one dose three days later for a total of two doses.
    
    
  
  
  • For pre-exposure prophylaxis if you have never received rabies vaccine before:
    
    • Adults and children—One dose on the first day, then one dose seven and twenty-one or twenty-eight days later for a total of three doses. The vaccine is injected into, or under the skin of, the muscle (deltoid) in the upper arm. Very young or small children may have the vaccine injected into the upper leg (thigh) muscle.
    
    
  
  
  • For pre-exposure prophylaxis if you have received rabies vaccine before (also known as a booster dose):
    
    • Adults and children—One dose injected into, or under the skin of, the muscle (deltoid) in the upper arm. Very young or small children may have the vaccine injected into the upper leg (thigh) muscle.
    
    
  
  

Missed Dose

Call your doctor or pharmacist for instructions.

Precautions While Using Rabavert

It is very important that your doctor check your progress at regular visits to make sure that this vaccine is working properly.

This vaccine may cause some people to become dizzy. Make sure you know how you react to this vaccine before you drive, use machines, or do anything else that could be dangerous if you are dizzy.

Rabavert Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

• Hives or skin rash

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Chills


• dizziness


• fever


• general feeling of discomfort or illness


• headache


• itching, pain, redness, or swelling at the place of injection


• muscle or joint aches


• nausea


• stomach or abdominal pain


• tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Gynodel

Gynodel may be available in the countries listed below.

Ingredient matches for Gynodel

Bromocriptine

Bromocriptine mesilate (a derivative of Bromocriptine) is reported as an ingredient of Gynodel in the following countries:

• Turkey

International Drug Name Search

Pasil

Pasil may be available in the countries listed below.

Ingredient matches for Pasil

Pazufloxacin

Pazufloxacin mesilate (a derivative of Pazufloxacin) is reported as an ingredient of Pasil in the following countries:

• Japan

International Drug Name Search

Haldol

Haldol is a brand name of haloperidol, approved by the FDA in the following formulation(s):

HALDOL (haloperidol decanoate - injectable; injection)

• 
  Manufacturer: JANSSEN PHARMS
  
  Approval date: January 14, 1986
  
  Strength(s): EQ 50MG BASE/ML ^[RLD][AO]


• 
  Manufacturer: JANSSEN PHARMS
  
  Approval date: January 31, 1997
  
  Strength(s): EQ 100MG BASE/ML ^[RLD][AO]

HALDOL (haloperidol lactate - injectable; injection)

• 
  Manufacturer: JANSSEN PHARMS
  
  Approved Prior to Jan 1, 1982
  
  Strength(s): EQ 5MG BASE/ML ^[RLD][AP]

Has a generic version of Haldol been approved?

Yes. The following products are equivalent to Haldol:

HALOPERIDOL (haloperidol lactate injectable; injection)

• 
  Manufacturer: APP PHARMS
  
  Approval date: March 9, 2001
  
  Strength(s): EQ 5MG BASE/ML ^[AP]


• 
  Manufacturer: BEDFORD
  
  Approval date: June 18, 2001
  
  Strength(s): EQ 5MG BASE/ML ^[AP]


• 
  Manufacturer: CLARIS LIFESCIENCES
  
  Approval date: August 25, 2004
  
  Strength(s): EQ 5MG BASE/ML ^[AP], EQ 5MG BASE/ML ^[AP]


• 
  Manufacturer: GLAND PHARMA LTD
  
  Approval date: August 25, 2004
  
  Strength(s): EQ 5MG BASE/ML ^[AP]


• 
  Manufacturer: PFIZER
  
  Approval date: September 14, 2009
  
  Strength(s): EQ 5MG BASE/ML ^[AP]


• 
  Manufacturer: SAGENT PHARMS
  
  Approval date: September 2, 2011
  
  Strength(s): EQ 5MG BASE/ML ^[AP], EQ 5MG BASE/ML ^[AP]


• 
  Manufacturer: TEVA PARENTERAL
  
  Approval date: August 29, 2001
  
  Strength(s): EQ 5MG BASE/ML ^[AP]

haloperidol decanoate injectable; injection

• 
  Manufacturer: APP PHARMS
  
  Approval date: December 19, 1997
  
  Strength(s): EQ 100MG BASE/ML ^[AO], EQ 50MG BASE/ML ^[AO]


• 
  Manufacturer: BEDFORD
  
  Approval date: January 30, 1998
  
  Strength(s): EQ 50MG BASE/ML ^[AO]


• 
  Manufacturer: BEDFORD
  
  Approval date: September 28, 1998
  
  Strength(s): EQ 100MG BASE/ML ^[AO]


• 
  Manufacturer: CLARIS LIFESCIENCES
  
  Approval date: February 28, 2000
  
  Strength(s): EQ 100MG BASE/ML ^[AO], EQ 50MG BASE/ML ^[AO]


• 
  Manufacturer: TEVA PARENTERAL
  
  Approval date: May 11, 1999
  
  Strength(s): EQ 100MG BASE/ML ^[AO], EQ 50MG BASE/ML ^[AO]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Haldol. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

There are no current U.S. patents associated with Haldol.

See also...

• Haldol Consumer Information (Wolters Kluwer)
• Haldol Consumer Information (Cerner Multum)
• Haldol Advanced Consumer Information (Micromedex)
• Haldol Intramuscular Advanced Consumer Information (Micromedex)
• Haloperidol Consumer Information (Wolters Kluwer)
• Haloperidol Decanoate Consumer Information (Wolters Kluwer)
• Haloperidol Solution Consumer Information (Wolters Kluwer)
• Haloperidol Tablets Consumer Information (Wolters Kluwer)
• Haloperidol Consumer Information (Cerner Multum)
• Alti-Haloperidol Advanced Consumer Information (Micromedex)
• Apo-Haloperidol Advanced Consumer Information (Micromedex)
• Novo-Peridol Advanced Consumer Information (Micromedex)
• Peridol Advanced Consumer Information (Micromedex)
• Pms-Haloperidol Advanced Consumer Information (Micromedex)
• Ratio-Haloperidol Advanced Consumer Information (Micromedex)
• Haloperidol Advanced Consumer Information (Micromedex)
• Haloperidol Intramuscular Advanced Consumer Information (Micromedex)
• Haloperidol AHFS DI Monographs (ASHP)
• Haloperidol Decanoate AHFS DI Monographs (ASHP)
• Haloperidol Lactate AHFS DI Monographs (ASHP)

Besacolin

Besacolin may be available in the countries listed below.

Ingredient matches for Besacolin

Bethanechol

Bethanechol Chloride is reported as an ingredient of Besacolin in the following countries:

• Japan

International Drug Name Search

Biozim

Biozim may be available in the countries listed below.

Ingredient matches for Biozim

Ceftazidime

Ceftazidime pentahydrate (a derivative of Ceftazidime) is reported as an ingredient of Biozim in the following countries:

• Indonesia

International Drug Name Search

Antemin

Antemin may be available in the countries listed below.

Ingredient matches for Antemin

Dimenhydrinate

Dimenhydrinate is reported as an ingredient of Antemin in the following countries:

• Switzerland

International Drug Name Search

Spidufen

Spidufen may be available in the countries listed below.

Ingredient matches for Spidufen

Ibuprofen

Ibuprofen is reported as an ingredient of Spidufen in the following countries:

• Brazil

International Drug Name Search

Oxopurin

Oxopurin may be available in the countries listed below.

Ingredient matches for Oxopurin

Pentoxifylline

Pentoxifylline is reported as an ingredient of Oxopurin in the following countries:

• Israel

International Drug Name Search

Piroctone Olamine

Piroctone Olamine may be available in the countries listed below.

Ingredient matches for Piroctone Olamine

Piroctone

Piroctone Olamine (USAN) is also known as Piroctone (Rec.INN)

International Drug Name Search

Glossary

Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Catogen

Catogen may be available in the countries listed below.

Ingredient matches for Catogen

Gentamicin

Gentamicin is reported as an ingredient of Catogen in the following countries:

• Venezuela

International Drug Name Search

Tricandil

Tricandil may be available in the countries listed below.

Ingredient matches for Tricandil

Mepartricin

Mepartricin is reported as an ingredient of Tricandil in the following countries:

• Italy


• Luxembourg


• Portugal

International Drug Name Search

Vinburnina

Vinburnina may be available in the countries listed below.

Ingredient matches for Vinburnina

Vinburnine

Vinburnina (DCIT) is also known as Vinburnine (Rec.INN)

International Drug Name Search

Glossary

DCIT	Denominazione Comune Italiana
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Grodoxin

Grodoxin may be available in the countries listed below.

Ingredient matches for Grodoxin

Doxycycline

Doxycycline is reported as an ingredient of Grodoxin in the following countries:

• Ethiopia

International Drug Name Search

Formoterol IPS

Formoterol IPS may be available in the countries listed below.

Ingredient matches for Formoterol IPS

Formoterol

Formoterol fumarate dihydrate (a derivative of Formoterol) is reported as an ingredient of Formoterol IPS in the following countries:

• Luxembourg

International Drug Name Search

Docetaxel

In the US, Docetaxel (docetaxel systemic) is a member of the drug class mitotic inhibitors and is used to treat Breast Cancer, Breast Cancer - Metastatic, Gastric Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, Prostate Cancer and Solid Tumors.

US matches:

• Docetaxel


• Docetaxel Intravenous

UK matches:

• Docetaxel Actavis 20mg/0.5ml concentrate and solvent for solution for infusion (SPC)
• Docetaxel Actavis 20mg/0.5ml Concentrate for Solution for Infusion (SPC)
• Docetaxel Actavis 80 mg/2 ml concentrate and solvent for solution for infusion (SPC)

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

L01CD02

CAS registry number (Chemical Abstracts Service)

0114977-28-5

Chemical Formula

C43-H53-N-O14

Molecular Weight

807

Therapeutic Category

Antineoplastic agent

Chemical Names

(2R,3S)-N-carboxy-3-phenylisoserine, N-tert-butyl ester, 13-ester with 5ß-20-epoxy-1,2α,4,7ß,10ß,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate (WHO)

(2R,3S)-4-acetoxy-2α-benzyloxy-13-[3-(N-tert-butoxycarbonyl)amino-2-hydroxy-3-phenyl]propionyl-5beta,20-epoxy-1,7beta,10beta-trihydroxy-9-oxotax-11-en-13α-ylester (IUPAC)

Foreign Names

• Docetaxelum (Latin)
• Docetaxel (German)
• Docétaxel (French)
• Docetaxel (Spanish)

Generic Names

• Docetaxel (OS: BAN)
• Docétaxel (OS: DCF)
• Docetaxol (IS)
• HSDB 6965 (IS)
• NSC-628503 (IS)
• RP 56976 (IS: RhônePoulencR)
• Docetaxel (OS: USAN)

Brand Names

• Asodocel
  Raffo, Argentina



• Brexel
  Kalbe, Indonesia



• Daxotel
  Biogalenic, Venezuela; Dabur, Georgia



• Docetaxel Biocrom
  Biocrom, Argentina



• Docetaxel Delta Farma
  Delta Farma, Argentina



• Docetaxel Rontag
  Rontag, Argentina



• Docetaxel Sandoz
  Sandoz, Argentina; Sandoz, Colombia



• Docetaxel Servycal
  Servycal, Argentina



• Docetaxel Varifarma
  Varifarma, Argentina



• Docetaxel
  Biocrom, Peru; GP Pharm, Peru; Servycal, Peru



• Docetere
  Dr Reddys, Sri Lanka; Dr. Reddy's, Peru



• Dolectran
  LKM, Argentina



• Donataxel
  Bioprofarma, Argentina



• Doxetal
  Richmond, Argentina; Richmond, Peru



• Oncodocel
  Tecnofarma, Colombia; Tecnofarma, Peru



• Plustaxano
  Dosa, Argentina



• Tautax
  Verofarm, Russian Federation



• Taxotere
  Aventis, Bosnia & Herzegowina; Aventis, Ghana; Aventis, Kenya; Aventis, Luxembourg; Aventis, Nigeria; Aventis, Peru; Aventis, Serbia; Aventis, Slovenia; Aventis, Tunisia; Aventis, Uganda; Aventis, Zimbabwe; Aventis Pharma, Norway; Aventis Pharma-F, Italy; Sanofi-Aventis, Australia; Sanofi-Aventis, Bangladesh; Sanofi-Aventis, Canada; Sanofi-Aventis, Denmark; Sanofi-Aventis, Dominican Republic; Sanofi-Aventis, Hong Kong; Sanofi-Aventis, Hungary; Sanofi-Aventis, Indonesia; Sanofi-Aventis, Ireland; Sanofi-Aventis, Israel; Sanofi-Aventis, Malaysia; Sanofi-Aventis, Oman; Sanofi-Aventis, Romania; Sanofi-Aventis, Russian Federation; Sanofi-Aventis, Slovakia; Sanofi-Aventis, Thailand; Sanofi-Aventis, Turkey; Sanofi-Aventis, Taiwan; Sanofi-Aventis, Taiwan; Sanofi-Aventis, United States; Sanofi-Aventis, Venezuela; Sanofi-Aventis, Vietnam; Sanofi-Aventis S.A.U., Spain; Sindan, Romania



• Taxuba
  Glenmark, India



• Texot
  Filaxis, Argentina



• Trazoteva
  Teva, Argentina



• Asodocel
  Asofarma, Argentina



• Daxotel
  Dabur, India; Dabur, Philippines



• Docetax
  Cemelog-BRS, Bulgaria



• Docetaxel Microsules
  Microsules, Argentina



• Docetere
  Ferron, Indonesia



• Oncotaxel
  Biotoscana, Colombia



• Taxotere
  Aventis, Brazil; Aventis, Czech Republic; Aventis, Iceland; Aventis, New Zealand; Aventis, Poland; Aventis, South Africa; Sanofi Aventis, Japan; Sanofi-Aventis, Argentina; Sanofi-Aventis, Austria; Sanofi-Aventis, Belgium; Sanofi-Aventis, Burkina Faso; Sanofi-Aventis, Benin; Sanofi-Aventis, Congo; Sanofi-Aventis, Switzerland; Sanofi-Aventis, Cote D'ivoire; Sanofi-Aventis, Chile; Sanofi-Aventis, Cameroon; Sanofi-Aventis, Colombia; Sanofi-Aventis, Costa Rica; Sanofi-Aventis, Germany; Sanofi-Aventis, Dominican Republic; Sanofi-Aventis, Ecuador; Sanofi-Aventis, Finland; Sanofi-Aventis, France; Sanofi-Aventis, Gabon; Sanofi-Aventis, United Kingdom; Sanofi-Aventis, Georgia; Sanofi-Aventis, Guinea; Sanofi-Aventis, Greece; Sanofi-Aventis, Guatemala; Sanofi-Aventis, Honduras; Sanofi-Aventis, Croatia (Hrvatska); Sanofi-Aventis, Mali; Sanofi-Aventis, Mexico; Sanofi-Aventis, Nicaragua; Sanofi-Aventis, Netherlands; Sanofi-Aventis, Panama; Sanofi-Aventis, Sweden; Sanofi-Aventis, Singapore; Sanofi-Aventis, Senegal; Sanofi-Aventis, El Salvador; Sanofi-Aventis, Togo; Sanofi-Aventis, Zaire; Sanofi-Aventis - Produtos farmacêuticos, S.A., Portugal

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
IUPAC	International Union of Pure and Applied Chemistry
IS	Inofficial Synonym
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
SPC	Summary of Product Characteristics (UK)
USAN	United States Adopted Name
WHO	World Health Organization

Click for further information on drug naming conventions and International Nonproprietary Names.

Oxa-CT

Oxa-CT may be available in the countries listed below.

Ingredient matches for Oxa-CT

Oxazepam

Oxazepam is reported as an ingredient of Oxa-CT in the following countries:

• Germany

International Drug Name Search

Dolacet

Pronunciation: a-SEET-a-MIN-oh-fen/HYE-droe-KOE-done
Generic Name: Acetaminophen/Hydrocodone
Brand Name: Examples include Dolacet and Stagesic

Dolacet contains acetaminophen. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4,000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor.

Dolacet is used for:

Treating moderate to moderately severe pain. It may also be used for other conditions as determined by your doctor.

Dolacet is an analgesic combination. Acetaminophen works by lowering a chemical in the brain that stimulates pain nerves. Hydrocodone, an opioid (narcotic) analgesic, works by binding to receptors in the brain and nervous system used by the body's natural "pain relievers." The combination may provide better pain relief than either medicine alone.

Do NOT use Dolacet if:

• you are allergic to any ingredient in Dolacet


• you have diarrhea associated with poisoning, antibiotic use, or a bacterial infection (from eating or drinking contaminated food or water)


• you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Dolacet:

Some medical conditions may interact with Dolacet. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you are allergic to other narcotic medicines (eg, medicines that contain codeine, morphine, oxycodone)


• if you have or have ever had alcoholism, substance abuse, narcotic dependence, or if you consume more than 3 alcoholic drinks per day


• if you have a history of suicidal thoughts or behavior


• if you have a head injury, increased pressure in the head, a brain injury or tumor, epilepsy, or seizures


• if you are having an asthma attack


• if you have an acute stomach or intestinal problem, chronic inflammation and ulceration of the bowel, or you have had recent abdominal surgery


• if you have adrenal gland problems; enlargement of the prostate gland; heart failure or lung disease, including shortness of breath; liver or kidney problems; thyroid disease; urinary blockage; or viral hepatitis

Some MEDICINES MAY INTERACT with Dolacet. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturate anesthetics (eg, thiopental), cimetidine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because serious side effects, such as increased sleepiness and decreased ability to breathe, may occur


• Naltrexone because it may decrease the effectiveness of Dolacet and withdrawal symptoms may occur in patients who have become physically dependent on opioids

This may not be a complete list of all interactions that may occur. Ask your health care provider if Dolacet may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Dolacet:

Use Dolacet as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Dolacet by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• If you miss a dose of Dolacet, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Dolacet.

Important safety information:

• Dolacet may cause drowsiness, dizziness, blurred vision, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Dolacet with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Dolacet; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Dolacet may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.


• Dolacet has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Dolacet may harm your liver. Your risk may be greater if you drink alcohol while you are using Dolacet. Talk to your doctor before you take Dolacet or other fever reducers if you drink more than 3 drinks with alcohol per day.


• Use Dolacet with caution in the ELDERLY; they may be more sensitive to its effects, especially possible decreased breathing and drowsiness.


• Dolacet should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Dolacet while you are pregnant. Dolacet is found in breast milk. Do not breast-feed while taking Dolacet.

When used for long periods of time or at high doses, Dolacet may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Dolacet stops working well. Do not take more than prescribed.

Some people who use Dolacet for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Dolacet, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Dolacet:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; constipation; dizziness; drowsiness; flushing; light-headedness; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; change in the amount of urine produced; fear; hearing change or loss; interrupted breathing; mental or mood changes; unusual tiredness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Dolacet side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bluish skin; cold/clammy skin; difficult or slow breathing; drowsiness leading to unresponsiveness or coma; excessive sweating; loss of function in the heart and lungs; nausea and vomiting; pinpoint pupils; seizure; stomach or intestinal pain.

Proper storage of Dolacet:

Store Dolacet at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not refrigerate. Do not freeze. Dispense in a tight, light-resistant container. Do not store in the bathroom. Keep Dolacet out of the reach of children and away from pets.

General information:

• If you have any questions about Dolacet, please talk with your doctor, pharmacist, or other health care provider.


• Dolacet is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Dolacet. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Dolacet resources

• Dolacet Side Effects (in more detail)
• Dolacet Use in Pregnancy & Breastfeeding
• Dolacet Drug Interactions
• Dolacet Support Group
• 0 Reviews for Dolacet - Add your own review/rating

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